Piramal Imaging announced that the US Food and Drug Administration (FDA) has approved Neuraceq.
Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline.
There are an estimated 7.7 million new cases of dementia each year worldwide. Alzheimer's disease accounts for 60-80% of all dementia diagnoses. However, a clinical diagnosis of probable AD is incorrect upon post-mortem histological investigation in 10-30% of cases.3
The Centers for Medicare & Medicaid Services (CMS) has declared it will cover a beta-amyloid PET scan for patients under Coverage with Evidence Development (CED) programs. The objective of these programs is to assess the impact of beta-amyloid scans on improving patient outcomes or advancing patient treatment options.
"Alzheimer's disease or any form of cognitive impairment is a daunting diagnosis," said Dr Ludger Dinkelborg, director of the board, Piramal Imaging. "For the patients and caregivers, the concern centers around understanding what the future holds. For physicians, the challenge is properly assessing the patient and determining the best care path."